# FDA 483 - SHODHANA LABORATORIES PRIVATE LIMITED - May 23, 2019

Source: https://www.keypedia.com/records/483/shodhana-laboratories-private-limited/f0430c62-b27b-4c5f-b21e-23bd61b995b8

> FDA 483 for SHODHANA LABORATORIES PRIVATE LIMITED on May 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SHODHANA LABORATORIES PRIVATE LIMITED
- Inspection Date: 2019-05-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shodhana Laboratories Limited, an API drug manufacturer in Hyderabad, India, from May 20-23, 2019, identified a critical deficiency in their manufacturing equipment cleaning validation procedure. The firm's cleaning validation study was found to be inaccurate and insensitive, failing to address worst-case conditions and utilizing inadequate sampling and analysis methods. This indicates a significant concern regarding the assurance of clean equipment for drug manufacturing.

## Related Officers

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Company: https://www.keypedia.com/companies/shodhana-laboratories-private-limited/8959db19-cb24-435f-8e94-d3f138113120

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1